Minimally invasive surgery has improved patient care by decreasing pain, shortening hospital stays, offering a faster recovery time and much smaller scars. In fact the surgical procedure is much shorter than standard procedures and offers less chance of infection, etc. These laparoscopic procedures are proving popular with the patient.
During minimally invasive procedures for the abdominal surgeries such as:                laparoscopic appendectomy (removal of the appendix);        laparoscopic cholecystectomy (removal of the gallbladder);        laparoscopic colectomy (removal of part or all of the colon);        laparoscopic fundoplication (corrects severe or persistent acid reflux);        laparoscopic hysterectomy (removal of the uterus); or        laparoscopic ventral hernia repair (repair of an abnormal bulging of the abdominal wall often at the site of a previous surgical incision),the surgeon makes a series of three to five small, dime-sized incisions in the patient's abdomen. Carbon dioxide gas is used to inflate the abdomen and create a working space between the internal organs and the skin. A small video camera, or scope, then is placed in one of the incisions, providing the surgeon with a magnified view of the patient's internal organs on a television monitor in the operating room. In some procedures, like MIP for colon conditions, a slightly larger incision may be needed.        
Thus, the procedure requires body access devices, which are utilized to introduce visualization equipment and operative instruments rather than a standard incision to access a required part of the body. Nonparallel instrumentation is necessary to create a “depth of field” (3-dimensional vision) and introduce a variety of instrumentation. This concept is commonly known as triangulation.
In the past multichannel devices have been used by the surgeon using narrow parallel channels (within the single multichannel access device). These narrow parallel channels have been found to limit the field of view and reduce depth perception. Thus, multichannel devices have not met the needs of the surgical community and are rarely used.
Nonparallel multiple access devices would allow the surgeon to introduce numerous types of instruments with triangulation through one body access opening. This concept would preserve triangulation and create the required field and depth of view while allowing the surgeon to utilize one body flange for multiple simultaneous tasks, which would be required to complete an operation on any applicable body area or space.
The current state of the art utilizes entry devices (body flanges) that have a similar cross-section as a silver dollar and incorporate a control head (gas in fusion port and sealing systems for insertable surgical instruments that have almost double cross-section as the part of the flange that attaches to the abdominal wall or body entry port. This means that large incisions will be used when operating on obese patients to allow for the large control head.
Wilk in U.S. Pat. No. 5,183,471 discloses a “Laparoscopic Cannula” that has a central conduit with a side crossing conduit that passes through the central conduit thereby creating an obstacle within the central conduit. The disclosure teaches a means to facilitate the temporary insertion of an extra laparoscopic instrument without having to make another perforation of the abdomen. The side crossing conduit will require that the central conduit be large; otherwise, a standard instrument would not be able to pass through the central conduit. The central conduit will allow a surgical instrument to “look” vertically downward over the operation point while the side crossing conduit will pass an instrument to one side of the operation point. Wilk continues to teach a second body flange for illumination and vision and does not discuss triangulation.
Wilk in U.S. Pat. No. 5,269,772 discloses a “Laparoscopic Cannula Assembly and Associated Method” which essentially is two parallel swiveling conduit passing through the same body opening and is a continuation-in-part of his '471 disclosure examined above. The parallel conduits do not cross over each other; however, the device will allow one instrument to be to one side of the operation point while the other instrument may be to the other side. The swiveling assembly will require a rather large opening in the abdomen wall. As in his '471 disclosure, he continues to teach a second body flange for illumination and vision and does not discuss triangulation.
Yoon in U.S. Pat. No. 6,066,090 discloses a “Branched Endoscope System” which discusses a single body flange having a plurality of tubes passing through the conduit for various surgical instruments. Yoon shows an embodiment in which the inside section of the body flange splits in two parts each having a bend thereby allowing a tube to overlook the other tube. The Yoon '090 device is designed to pass through the current art body flange having a single conduit.
Yoon in U.S. Pat. No. 6,277,064 discloses a “Surgical Instrument with Rotatably Mounted Offset Endoscope.” The apparatus is a variation of the '090 device and is designed to pass through the current art body flange having a single conduit.
Wenner et al. in U.S. Pat. No. 6,440,061 disclose a “Laparoscopic Instrument System for Real-Time Biliary Exploration and Stone Removal.” This device has multiple ports within its system, but, like Yoon, is designed to pass through the current art body flange having a single conduit.
Bimbo et al. in U.S. Pat. No. 6,551,270 disclose a “Dual Lumen Access Port.” The device is essentially a current state of the art body flange with parallel entry ports that open into a single conduit which will accept two surgical tools through one body flange without ensuring a three dimensional field of view. Bimbo teaches multiple instruments through a single conduit but does not explore the concept of a single body flange replacing surgical procedures using multiple body flanges.
Piskun in U.S. Pat. No. 6,454,783 discloses “Laparoscopic Instruments and Trocar Systems for Trans-umbilical Laproscopic (sic) Surgery.” Piskun discloses an instrument system that markedly increases the work space between the hands of the surgeon. The system includes s-shaped laparoscopic tools and associated curved trocars (sealable conduit passing through the umbilicus). The disclosure goes further to propose at least one curved trocar contained within an inflatable unit for placement through the umbilicus—essentially an inflatable body flange.
The inventors in their earlier application, of which this is a continuation-in-part, disclosed a body flange or body anchor system which provided an apparatus and method that would allowed the surgeon to perform minimally invasive operations with body flanges having a smaller overall cross-section while allowing for triangulation within the patient. Such a device and method will result in fewer incisions for body access openings thus further decreasing the pain caused by surgery and further decreasing the recovery time and further reducing the risk of infection. However, as their device was developed it was discovered that a perfectly round shape tended to swivel in the umbilicus and tended to lift out of the umbilicus in spite of the sutures.
It was discovered that if the shape of the anchor was modified to be oval in shape then the anchor would not as easily rotate. At the same time it was discovered that if a stabilizer extension (shaped somewhat like the toe of a boot) was added to the lower inside part of the anchor the tendency to lift out of the umbilicus was further reduced. The stabilizer extension added one further advantage to the body anchor in that it tended to elevate fat and peritoneum inside the patient's body thereby keeping the internal opening clear for surgical instruments.
During further experimentation with the crisscrossed anchor employing the “boot” stabilizer, it was discovered that a substantial improvement in the ease of instrument positioning with the body cavity would occur if the conduit passages were “bored-out” into the shape of a cone either above or below the point in the anchor where it passes into the body. As a part of this discovery, it was noted that the conical conduit must be angled away from each other substantially like bicycle spokes while maintaining a crisscross pattern (for three-dimensional viewing) resulting in trajectories that may be nonparallel or parallel which may of may not crisscross within the actual anchor itself.
Further development lead to a concept to allow for a fourth conduit about the outside of the anchor without significantly increasing the “diameter” of the anchor. At the same time it was realized that if the conduit passages were made of a flexible material, then the overall triangulation could be substantially increased.